Amoxicillin - Generic Drug Details

What are the generic sources for amoxicillin and what is the scope of freedom to operate?

Amoxicillin is the generic ingredient in twenty-five branded drugs marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Us Antibiotics, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, Ph Health, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Takeda Pharms Usa, Cumberland, Phathom, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, Teva Pharms Usa, and Talicia Holdings, and is included in one hundred and twenty-six NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has eleven patent family members in six countries.

There are forty-six drug master file entries for amoxicillin. Forty suppliers are listed for this compound.

Summary for amoxicillin

International Patents:	11
US Patents:	12
Tradenames:	25
Applicants:	34
NDAs:	126
Drug Master File Entries:	46
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	680
Patent Applications:	5,199
Drug Prices:	Drug price trends for amoxicillin
Drug Sales Revenues:	Drug sales revenues for amoxicillin
What excipients (inactive ingredients) are in amoxicillin?	amoxicillin excipients list
DailyMed Link:	amoxicillin at DailyMed

See drug prices for amoxicillin

See drug sales revenues for amoxicillin

Recent Clinical Trials for amoxicillin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yueyue Li	NA
Qilu Hospital of Shandong University, Dezhou Branch	NA
Guanxian People's Hospital	NA

See all amoxicillin clinical trials

Pharmacology for amoxicillin

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for amoxicillin

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for amoxicillin

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for amoxicillin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	091568-001	Jan 20, 2012	AB	RX	No	No
Us Antibiotics	AUGMENTIN '250'	amoxicillin; clavulanate potassium	TABLET, CHEWABLE;ORAL	050597-002	Jul 22, 1985		DISCN	Yes	No
Labs Atral	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	062528-001	Aug 7, 1985		DISCN	No	No
Mylan	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	062067-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Us Antibiotics	AMOXIL	amoxicillin	FOR SUSPENSION;ORAL	062226-002	Approved Prior to Jan 1, 1982	AB	RX	No	No
Teva	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065089-002	May 25, 2004	AB	RX	No	Yes
Sun Pharm Inds Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065132-002	Mar 19, 2003		DISCN	No	No

Expired US Patents for amoxicillin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,544,555
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,723,341
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,669,948

International Patents for amoxicillin

Country	Patent Number	Title	Estimated Expiration
Australia	2006321782	Pharmaceutical compositions and methods for improved bacterial eradication
Australia	2006351475	Modified release amoxicillin products
Canada	2635378	COMPOSITIONS PHARMACEUTIQUES ET METHODES POUR ERADICATION BACTERIENNE AMELIOREE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)
Canada	2635606	PRODUITS D'AMOXICILLINE A LIBERATION MODIFIEE (MODIFIED RELEASE AMOXICILLIN PRODUCTS)
China	101563466	Modified release amoxicillin products
European Patent Office	1968586	COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES POUR ÉRADICATION BACTÉRIENNE AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)
European Patent Office	1969134	PRODUITS D'AMOXICILLINE À LIBÉRATION MODIFIÉE (MODIFIED RELEASE AMOXICILLIN PRODUCTS)